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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Queens Health Network Thomas Jefferson University Hospital University of Southern California - Norris Cancer Hospital Davidoff Cancer Center St. Vincent’s Catholic Medical Center Krankenhaus Nordwest Georgia Memorial Health |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00582257 |
The purpose of this study is to establish a gastric cancer registry. A registry is a database of information. With the registry, we can learn more about the genetic causes of gastric cancer in order to develop better methods of early diagnosis, prevention, and treatment of gastric cancers. As part of this study, you will be asked to join a registry of families who are affected with various forms of gastric cancer. These registries are important because they may help physicians better manage gastric cancer now and in the future. Participating in the Early Onset and Familial Gastric Cancer Registry can also be educational for families, since it will provide important information to patients, families, and physicians. All of this will help to further our understanding of genetic causes of gastric cancer and eventually, help determine better ways to diagnose, treat, and survey patients with gastric cancer and people who may have a higher risk for gastric cancer.
Condition |
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Gastric Cancer |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Early Onset and Familial Gastric Cancer Registry |
Germline DNA and Tissue
Estimated Enrollment: | 200 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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High Genetic Risk Cohorts:
Early Onset Gastric Cancer - diagnosis of gastric cancer before the age of 50 without a family history of the disease. Familial Gastric Cancer - having a family history of gastric cancer as defined as one first degree relative or 2 second degree relatives. |
Low Genetic Risk Cohorts:
Sporadic Gastric Cancer - gastric cancer that appears to have occurred by random or sporadic mutation. Specifically, a patient with gastric cancer not eligible for either High Genetic Risk cohort. Non-Cancer Control - a participant without gastric cancer or other known malignancy, and having no family history of gastric cancer. |
On a global basis, cancer of the stomach is the third most prevalent malignancy, with 947,000 expected new cases in 2000, and the second leading cancer cause of death (734,000 deaths annually). In the United States in 2003, approximately 22,400 cases of gastric cancer will be diagnosed, and 12,100 patients will die from this disease1. The prognosis of this disease is poor with 5-year relative survival rate of less than 20% for advanced disease. The etiology of gastric cancer is attributable to both environmental and hereditary factors. In the subset of patients with early onset disease and in particular among familial forms of this disease, inherited susceptibility appears to play a dominant role. No single mutation has been identified as responsible for early onset gastric cancer. Recent evidence has emerged supporting the role of germline mutations in the E-cadherin gene (CDH1) as conferring increased susceptibility to early onset diffuse type gastric cancer and better understanding of other genes that predispose to gastric cancer tumorigenesis is anticipated in the next several years2, 3. The primary purpose of this protocol is to establish a prospective registry with detailed family history, gastric cancer risk factors, germline DNA, and matched tumor and normal tissue for patients with early onset or familial gastric cancer and their at-risk relatives. With this aim in mind, we have amended the registry to include populations who are at low risk for germline etiology for the development of gastric cancer. This includes a cohort of patients with gastric cancer who appear to have developed the disease sporadically, as well as a cohort of non-cancer control patients. Secondary objectives are 1) To measure the incidence of germline mutations in CDH1 among "early onset" and "familial" gastric cancer patients and their relatives to determine the importance of this variant in gastric cancer susceptibility and 2) To measure the prevalence of abnormal gastric pathology among the cancer-free relatives of patients with "early onset" and "familial" gastric cancer. In this research protocol, early onset gastric cancer (EOGC) is defined as disease with age of onset before 50 that arises in the absence of family history of gastric cancer or known hereditary cancer syndrome. Familial gastric cancer (FGC) is defined as disease that occurs among individuals with at least one affected first degree relative or two or more affected second degree relatives.Patients eligible for the "sporadic" cohort are those not eligible for the EOGC or FGC. We will also establish a "low risk" cohort for comparison. Patients eligible for the "low risk" cohort are those not eligible for the EOGC or FGC. Study participants will fill out a questionnaire on their family history and on their gastric cancer risk factors. Participants will be invited to provide a sample of germline DNA for future genetic studies. Select high risk individuals, for example those that meet criteria for Diffuse Hereditary Gastric Cancer(DHGC), will be invited to participate in genetic counseling which is required prior to evaluation for CDH1 gene mutations. In addition, participants will be invited to provide tissue (tumor and normal) where available, both fresh frozen and paraffin-embedded if possible. At risk relatives of patients with EOGC/FGC will also be invited for a single upper endoscopy screening test. At select sites, at risk relatives of patients with EOGC/FGC will also be invited for a single upper endoscopy screening test. The Early Onset/Familial Gastric Cancer Registry will serve as a source of clinical and pathological material that can be used to identify future genetic abnormalities that may or may not predispose the development of gastric cancer in these high-risk families and will help define a cohort for participation in future chemoprevention/screening studies. Moreover, it will ensure that there is a coherent unified approach for management of this rare group of patients at Memorial Sloan-Kettering.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at MSK or collaborating centers. If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participation and discuss the study and their potential for enrolling in the research study. Potential subjects contacted by their treating physician will be referred to the investigator/research staff of the study.
Inclusion Criteria:
High Genetic Risk Cohorts: Participants at high genetic risk for the development of gastric cancer may qualify for either the Early Onset Cancer group, Familial Gastric Cancer group, or the High Risk Relative group. Inclusion criteria for each group is defined below:
•Early Onset Gastric Cancer Patient:
These patients will be asked to sign a "Patient Consent Form"
•Familial Gastric Cancer Patient:
Note, participants who present to the registry with a documented CDH1 mutation within their kindred need not have a diagnosis of gastric/ gastroesophageal junction to enroll within the FGC patient cohort. Moreover, the degree of relation does not affect study eligibility.
These patients will be asked to sign a "Patient Consent Form"
Patients with both early age at onset and family history will be categorized and analyzed as part of the FGC group. Thus, a 30-year old patient with an affected first degree relative would be categorized as "Familial" for the purposes of this protocol even though they also have age of onset before age 50.
When High Genetic Risk gastric cancer patients are identified, we will ask for permission to confirm the diagnosis in their affected relatives by obtaining pathology reports and will ask them to contact their first-degree relatives for potential participation in the study.
High Risk relatives:
These patients will be asked to sign a "Relative consent form"
Low Genetic Risk Cohorts: Participants at low genetic risk for the development of gastric cancer may qualify for either the Sporadic Gastric Cancer or Non Cancer Control. Inclusion for each group is defined below:
•Sporadic Gastric Cancer patients:
These patients will be asked to sign a "Sporadic Gastric Cancer consent form"
•Non Cancer Control :
These patients will be asked to sign a "Non Cancer Control consent form"
At select sites, relatives of participants eligible for the High Genetic Risk cohorts will be invited to undergo a baseline EGD to examine the prevalence of mucosal pathology if they meet the criteria in the protocol AND:
Exclusion Criteria:
Contact: Manish Shah, MD | shah1@mskcc.org |
United States, New Jersey | |
Memorial Sloan-Kettering Cancer Center at Basking Ridge | Recruiting |
Basking Ridge, New Jersey, United States, 07920 | |
Contact: Manish Shah, MD shah1@mskcc.org | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Manish Shah, MD shah1@mskcc.org | |
Memorial Sloan-Kettering Cancer Center at Commack | Recruiting |
Commack, New York, United States, 11725 | |
Contact: Manish Shah, MD 212-639-5209 shah1@mskcc.org | |
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center | Recruiting |
Rockville Centre, New York, United States, 11570 | |
Contact: Manish Shah, MD shah1@mskcc.org | |
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center | Recruiting |
Sleepy Hollow, New York, United States, 10591 | |
Contact: Manish Shah, MD shah1@mskcc.org |
Principal Investigator: | Manish Shah, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Manish Shah, MD ) |
Study ID Numbers: | 05-118 |
Study First Received: | December 21, 2007 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00582257 |
Health Authority: | United States: Food and Drug Administration |
Gastric Cancer Stomach Cancer |
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases |
Stomach Neoplasms Gastrointestinal Neoplasms Stomach cancer |
Neoplasms Neoplasms by Site |